MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Pumping Stopped (1503); Insufficient Flow or Under Infusion (2182)

Patient Problems Abdominal Pain (1685); Therapeutic Response, Decreased (2271); Malaise (2359); No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving morphine 25 mg/ml; 21.5 mg/day via an implantable pump.Indication for use was non-malignant pain.The date of the event was (b)(6) 2018.It was reported a motor stall occurred (b)(6) 2018 at 8:15 pm with no recovery; tube set occurred (b)(6) 2018.The patient did not recently have magnetic resonance imaging (mri).Electromagnetic interference (emi) was ruled out as the cause of the stall.The pump was refilled (b)(6) 2018 and there was a reservoir volume discrepancy.The expected residual volume (erv) was 9 ml; the actual residual volume (arv) was 34 ml.The audible pump alarm was confirmed.The pump had six months of battery longevity left.No symptoms were reported.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was unknown if any environmental/external/patient factors that may have led or contributed to the motor stall.The pump was replaced (b)(6) 2018.The issue was resolved.Patient weight and medical history were asked and will not be made available.Patient status was alive - no injury.

Manufacturer Narrative

H6: patient code c76143 is no longer applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.The patient experienced flu-like symptoms and withdrawal.The pump was sent to pathology per their protocol.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).On 10/19/2018 it was discovered that the pump failed.The patient experienced increased pain in their abdomen and decreased function.The patient presented to the emergency department and was admitted to the hospital.The volume discrepancy and motor stall have been resolved.The patient¿s weight was unknown.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7991332
• MDR Text Key: 124600041
• Report Number: 3004209178-2018-23586
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2018
• Date Device Manufactured: 02/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR